OrthoPediatrics PediFoot Deformity Correction System 00-1007-1408

GUDID 00841132157657

3.5mm Recon Plate, 8 Hole

ORTHOPEDIATRICS CORP.

Growth-correction orthopaedic fixation plate kit

• Primary Device ID: 00841132157657
• NIH Device Record Key: e02e3c17-7377-4f31-98e7-a1bafa6a41d9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OrthoPediatrics PediFoot Deformity Correction System
• Version Model Number: 00-1007-1408
• Catalog Number: 00-1007-1408
• Company DUNS: 796416191
• Company Name: ORTHOPEDIATRICS CORP.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(574)268-6379
• Email: jjaskula@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: jjaskula@orthopediatrics.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841132157657 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190992

FDA Product Code

• HRS: Plate, fixation, bone

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-11-19
• Device Publish Date: 2019-11-11

On-Brand Devices [OrthoPediatrics PediFoot Deformity Correction System]

• 00841132145081: FOOT PUSHER LID
• 00841132145074: FOOT PUSHER TRAY
• 00841132145067: FOOT PUSHER KNOB
• 00841132145050: FOOT PUSHER HANDLE
• 00841132145043: FOOT PUSHER PLATFORM, SMALL
• 00841132145036: FOOT PUSHER PLATFORM, LARGE
• 00841132159866: 1.6mm Mini Tack, 25mm, Smooth
• 00841132159859: 1.6mm Mini Tack, 15mm, Smooth
• 00841132159842: 1.6mm Mini Tack, 8mm, Smooth
• 00841132159835: Insert Tray
• 00841132159828: Screw Caddy Lid
• 00841132159811: Plate Caddy
• 00841132159804: Screw Caddy
• 00841132159798: Lid
• 00841132159781: Case
• 00841132159774: 2.0mm Olive Wire, 30mm
• 00841132159767: 2.0mm Olive Wire, 25mm
• 00841132159750: 2.0mm Olive Wire, 20mm
• 00841132159743: 2.0mm Olive Wire, 15mm
• 00841132159736: 2.0mm Olive Wire, 10mm
• 00841132159729: 2.5mm Olive Wire, 30mm
• 00841132159712: 2.5mm Olive Wire, 25mm
• 00841132159705: 2.5mm Olive Wire, 20mm
• 00841132159699: 2.5mm Olive Wire, 15mm
• 00841132159682: 2.5mm Olive Wire, 10mm
• 00841132159675: 2.5mm K Wire, Threaded tip, 150mm
• 00841132159668: 2.5mm K Wire, Threaded tip, 100mm
• 00841132159651: 2.5mm K Wire, Threaded tip, 75mm
• 00841132159644: 2.5mm K Wire, Smooth, 150mm
• 00841132159637: 2.5mm K Wire, Smooth, 100mm
• 00841132159620: 2.5mm K Wire, Smooth, 75mm
• 00841132159613: 2.0mm Guide Wire, Partially Threaded Shaft, 110mm, 35mm Thread
• 00841132159606: 2.0mm Guide Wire, Partially Threaded Shaft, 110mm, 30mm Thread
• 00841132159590: 2.0mm Guide Wire, Partially Threaded Shaft, 110mm, 25mm Thread
• 00841132159583: 2.0mm Guide Wire, Partially Threaded Shaft, 110mm, 20mm Thread
• 00841132159576: 2.0mm K Wire, Threaded tip, 150mm
• 00841132159569: 2.0mm K Wire, Threaded tip, 100mm
• 00841132159552: 2.0mm K Wire, Threaded tip, 75mm
• 00841132159545: 2.0mm K Wire, Smooth, 150mm
• 00841132159538: 2.0mm K Wire, Smooth, 100mm
• 00841132159521: 2.0mm K Wire, Smooth, 75mm
• 00841132159514: 1.6mm K Wire, Threaded tip, 150mm
• 00841132159507: 1.6mm K Wire, Threaded tip, 100mm
• 00841132159491: 1.6mm K Wire, Threaded tip, 75mm
• 00841132159484: 1.6mm K Wire, Smooth, 150mm
• 00841132159477: 1.6mm K Wire, Smooth, 100mm
• 00841132159460: 1.6mm K Wire, Smooth, 75mm
• 00841132159453: Heel Handler
• 00841132159446: Bending Iron
• 00841132159439: T8 Solid Driver, Non-Retaining